Current through Reg. 49, No. 38; September 20, 2024
(a)
Rotary wing aircraft (helicopters) operated by a licensed emergency medical
services (EMS) provider shall be at the mobile intensive care level. Persons or
entities operating rotary wing air ambulances must direct and control the
integrated activities of both the medical and aviation components. Although the
aircraft operator is directly responsible to the Federal Aviation
Administration (FAA) for the operation of the aircraft, typically the
organization in charge of the medical functions directs the combined efforts of
the aviation and medical components during patient transport operations.
Licensed rotary wing aircraft must also meet the requirements of §
157.11
of this title (relating to Requirements for an EMS Provider License) as long as
the Airline Deregulation Act of 1978,
49 U.S.C.
§
41713(b)(1) et seq.
is not violated.
(b) When being
used as an ambulance, the helicopter shall:
(1) be configured so that the medical
personnel have adequate access to the patient in order to begin and maintain
basic and advanced life support treatment;
(2) have an entry that allows loading and
unloading of a patient without excessive maneuvering (no more than 45 degrees
about the lateral axis and 30 degrees about the longitudinal axis); and does
not compromise functioning of monitoring systems, intravenous (IV) lines, or
manual or mechanical ventilation;
(3) have a supplemental lighting system in
the event standard lighting is insufficient for patient care that includes:
(A) a self-contained lighting system powered
by a battery pack or a portable light with a battery source; and
(B) a means to protect the pilot's night
adaptation vision. (Use of red lighting or low intensity lighting in the
patient care area is acceptable if not able to isolate the patient care
area);
(4) have an
electric power outlet with an inverter or appropriate power source of
sufficient output to meet the requirements of the complete specialized
equipment package without compromising the operation of any electrical aircraft
equipment;
(5) have protection of
the pilot's flight controls, throttles and radios from any intended or
accidental interference by the patient, air medical personnel or equipment and
supplies; and
(6) have an internal
medical configuration located so that air medical personnel can provide patient
care consistent with the scope of care of the air medical service, to include:
(A) the space necessary to ensure the
patient's airway is maintained and to provide adequate ventilatory support from
the secured, seat-belted position of the air medical personnel;
(B) those aircraft with gaseous oxygen
systems have equipment installed so that medical personnel can determine if
oxygen is on by in-line pressure gauges mounted in the patient care area.
Aircraft using liquid or gaseous oxygen should have equipment installed:
(i) with each gas outlet clearly marked for
identification;
(ii) with oxygen
flow capable of being stopped at the oxygen source from inside the aircraft;
and
(iii) so that the measurement
of the liter flow and quantity of oxygen remaining is accessible to air medical
personnel while in flight. All flow meters and outlets must be padded, flush
mounted, or so located as to prevent injury to air medical personnel; or there
shall be an operational policy stating that attendants wear helmets;
(C) hangers/hooks available to
secure (IV) solutions in place or a mechanism to provide high flow fluids if
needed:
(i) all IV hooks shall be padded,
flush mounted, or so located as to prevent head trauma to the air medical
personnel in the event of a hard landing or emergency with the aircraft; or an
operational policy stating that attendants wear helmets; and
(ii) glass containers shall not be used
unless required by medication specifications and properly vented;
(D) provision for medication which
allows for protection from extreme temperatures if it becomes environmentally
necessary;
(E) secure positioning
of cardiac monitors, defibrillators, and external pacers so that displays are
visible to medical personnel; and
(F) shall assure that all specialized medical
equipment is secured throughout transport with adequately engineered designated
mounts as approved by FAA.
(c) An air ambulance provider shall meet the
responsibilities of EMS providers as in §
157.11
of this title (relating to Requirements for an EMS Provider License) and in
addition shall:
(1) submit proof that the
rotor-wing aircraft provider carries bodily injury and property damage
insurance with a company licensed to do business in Texas in order to secure
payment for any loss or damage resulting from any occurrence arising out of or
caused by the operation or use of any of the certificate holder's
aircraft.
(2) submit proof that the
air ambulance provider carries professional liability insurance coverage in the
minimum amount of $500,000 per occurrence, with a company licensed to do
business in Texas in order to secure payment for any loss or damage resulting
from any occurrence arising out of or caused by the care or lack of care of a
patient;
(3) submit a list of all
aircraft with the registration number or "N" number for the helicopters in the
possession of the provider.
(4)
submit a letter of agreement that all helicopters shall meet the specifications
of subsection (b) of this section, if the aircraft is leased from a
pool;
(5) allow visual and physical
inspection of each aircraft and of the equipment to be used on each vehicle for
the purpose of determining compliance with the vehicle and equipment
specifications within this section; and
(6) submit a copy of current Federal Aviation
Administration (FAA) carrier, operational, and airworthiness certification, as
per U.S, Code of Federal Regulations, Title 14, Subchapter G, Part
135).
(d) The air
ambulance provider shall employ a medical director who shall meet the following
qualifications:
(1) be a physician approved
by the department and in practice;
(2) have knowledge and experience consistent
with the transport of patients by air;
(3) be knowledgeable in aeromedical
physiology, stresses of flight, aircraft safety, patient care, and resource
limitations of the aircraft, medical staff and equipment;
(4) have access to consult with medical
specialists for patient(s) whose illness and care needs are outside the medical
director's area of practice;
(5)
shall comply with the requirements in the Medical Practice Act, Occupations
Code, Chapters 151 - 168, and 22 Texas Administrative Code, Chapter 197;
and
(6) have knowledge on Texas EMS
laws and regulations affecting local, regional and state operations.
(e) The physician shall fulfill
the following responsibilities:
(1) ensure
that there is a comprehensive plan/policy to address selection of appropriate
aircraft, staffing and equipment;
(2) be involved in the selection, hiring,
educating, training and continuing education of all medical
personnel;
(3) be responsible for
overseeing the development and maintenance of a continuous quality improvement
program;
(4) ensure that there is a
plan to provide direction of patient care to the air medical personnel during
transport. The system shall include on-line (radio/telephone) medical control,
and/or an appropriate system for off-line medical control such as written
guidelines, protocols, procedures, patient specific written orders or standing
orders;
(5) participate in any
administrative decision making processes that affect patient care;
(6) ensure that there is an adequate method
for on-line medical control, and that there is a defined plan or procedure and
resources in place to allow off-line medical control;
(7) oversee the review, revision and
validation of written medical policies and protocols annually for the treatment
and transportation of adult, pediatric, and neonatal patients; and
(8) attest to the following capabilities:
(A) experience consistent with the transport
of patients by air;
(B) knowledge
of aeromedical physiology, stresses of flight, aircraft safety, resources
limitations of the aircraft;
(C)
knowledge on Texas EMS laws and regulations affecting local, regional and state
operations; and
(D) awareness that
the EMS provider has provided safety education for ground emergency services
personnel.
(f) There shall be two Texas
licensed/certified personnel on board the helicopter when in service. A waiver
to the Texas license/certification may be granted for personnel employed by
providers in New Mexico, Oklahoma, Arkansas, Kansas, Colorado and Louisiana who
respond in Texas and are licensed in their respective state. Staffing of
vehicles shall be as follows:
(1) when
responding to an emergency scene, at least one of the personnel shall be a
paramedic;
(2) when responding for
an inter-facility transfer, at least one of the personnel performing patient
care duties shall be a certified or licensed paramedic, registered nurse or
physician. The qualifications and numbers of air medical personnel shall be
appropriate to patient care needs;
(3) when responding as in paragraphs (1) and
(2) of this subsection, the second person may be a certified or licensed
paramedic, registered nurse, or a physician; and
(4) air medical personnel shall not be
assigned or assume the cockpit duties of the flight crew members concurrent
with patient care duties and responsibilities.
(g) Documentation of successful completion of
education specific to the helicopter transport environment in general and the
licensee's operation specifically shall be required. The curriculum shall be
consistent with the Department of Transportation (DOT) Air Medical Crew -
National EMS Education Standards or equivalent program and each attendant's
qualifications shall be documented.
(h) Medical supplies and equipment shall be
consistent with the service's scope of care as defined in the
protocols/standing orders for adult, pediatric, and neonatal patients. Medical
equipment shall be functional without interfering with the avionics nor should
avionics interfere with the function of the medical equipment. Additionally,
the following equipment, clean and in working order, must be on the aircraft or
immediately available for all providers:
(1)
one or more stretchers capable of being secured in the aircraft which meet the
following criteria:
(A) can accommodate an
adult, 6 feet tall, weighing 212 pounds. There shall be restraining devices or
additional appliances available to provide adequate restraint of all patients
including those under 60 pounds or 36 inches in height;
(B) shall have the head of the primary
stretcher, with recommended manufacturer's or FAA approved restraint system in
place, capable of being elevated up to 30 degrees. The elevating section shall
not interfere with or require that the patient or stretcher securing straps and
hardware be removed or loosened;
(C) shall be sturdy and rigid enough that it
can support cardiopulmonary resuscitation. If a backboard or equivalent device
is required to achieve this, such device will be readily available;
(D) shall have a pad or mattress impervious
to moisture and easily cleaned and disinfected according to Occupational Safety
and Health Administration (OSHA) bloodborne pathogen requirements;
and
(E) shall have a supply of
linen for each patient;
(2) adequate amounts of oxygen and masks (for
anticipated liter flow and length of flight with an emergency reserve)
available for every mission;
(3)
one portable oxygen tank;
(4) a
back-up source of oxygen (of sufficient quantity to get safely to a facility
for replacements). A back-up source may be the required portable tank if the
tank is accessible in the patient care area during flight;
(5) airway adjuncts as follows:
(A) oropharyngeal airways in at least five
assorted sizes, including for adult, pediatric, and neonatal patients;
and
(B) nasopharyngeal airways in
at least three sizes with water soluble lubricant;
(6) at least one suction unit which is
portable (bulb syringes or foot pump is not acceptable);
(7) the following items in amounts and sizes
as specified on a list signed by the medical director:
(A) IV solutions;
(B) IV catheters;
(C) endotracheal tubes;
(D) medications;
(E) any specialized equipment required in
medical treatment protocols/standing orders;
(F) pressure bag;
(G) tourniquets, tape, dressings;
and
(H) container appropriate to
contain used sharp devices (needles, scalpels) which meets OSHA
requirements;
(8)
assessment equipment as follows:
(A)
equipment suitable to determine blood pressure of an adult, pediatric, and
neonatal patients during flight;
(B) stethoscope;
(C) penlight/flashlight;
(D) heavy duty bandage scissors;
(E) pulse oximeter;
(F) external cardiac pacing device;
and
(G) IV infusion pump capable of
strict mechanical control of an IV infusion drip rate. Passive devices such as
dial-a-flow are not acceptable;
(9) bandages and dressings as follows:
(A) sterile dressings such as 4x4s, abdominal
pads;
(B) bandages such as Kerlix,
Kling; and
(C) tape in various
sizes;
(10) container(s)
and methods to collect, contain, and dispose of body fluids such as emesis,
oral secretions, and blood consistent with OSHA bloodborne pathogen
requirements;
(11) infection
control equipment. The licensee shall have a sufficient quantity of the
following supplies for all air medical personnel, and each flight crew member,
and all ground personnel with incidental exposure risks according to OSHA
requirements which includes but is not limited to:
(A) protective gloves;
(B) protective gowns;
(C) protective eyewear;
(D) protective face masks, National Institute
for Occupational Safety and Health (NIOSH) approved N95 or greater;
(E) an approved bio-hazardous waste plastic
bag or impervious container to receive and dispose of used supplies;
and
(F) handwashing capabilities or
antiviral towelettes;
(12) an adequate trash disposal system
exclusive of bio-hazardous waste control provisions;
(13) security of medications, fluids, and
controlled substances shall be maintained by each air ambulance licensee in
compliance with local, state, and federal drug laws;
(14) 12-lead cardiac monitor defibrillator -
DC battery powered portable monitor/defibrillator with paper printout,
accessories and supplies, with sufficient power supply to meet demands of the
mission;
(15) quantity and type of
drugs and specialized equipment as specified on the medical director's
list;
(16) permanently installed
climate control equipment to provide an environment appropriate for the medical
needs of patients; and
(17)
survival kit which shall include, but not be limited to, the following items
which are appropriate to the terrain and environments the provider operates
over:
(A) instruction manual;
(B) water;
(C) shelter-space blanket;
(D) knife;
(E) signaling devices;
(F) compass; and
(G) fire starting items.